BEUDAMED
    FDA Registration Active 🇮🇳 India

    Encor Probe

    Reg #: 3015924373 · FEI: 3015924373 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AUSA Medical Device Pvt Ltd
    Registration Number
    3015924373
    FEI Number
    3015924373
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Plot no. 15B Bommasandara Industrial Area, Anekal Taluk
    City
    Bangalore Karnataka
    Country
    IN

    Regulatory Submissions

    510(k) Number
    K040842

    Owner / Operator

    Firm Name
    Adroit USA Inc
    Operator Number
    10037845
    Address
    1043 Serpentine Lane, Suite A
    City
    Pleasanton
    State
    CA
    Postal Code
    94566
    Country
    US
    Correspondent
    Arpan Bajaj

    US Agent

    Business Name
    Adroit USA Inc
    Contact Name
    Arpan Bajaj
    Address
    1043 Serpentine Lane, Suite A
    City
    Pleasanton
    State
    CA
    ZIP
    94566
    Country
    US
    Email
    [email protected]
    Phone
    510 2991796

    Products

    Device Name Product Code
    Instrument, Biopsy KNW

    Proprietary Names

    Encor Probe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)